ClinicalTrials.gg
Not yet recruitingNCT07927634CALM-PRICKUpdated Nov 10, 2026

Evaluating Ceramol Beta Complex® Cream to Relieve Itching After Skin Allergy Tests in Children Aged 6-12 Years (CALM-PRICK)

An interventional study of Application of antipruritic cream and The control group will receive an emollient cream (B), prepared by the hospital pharmacy, without antipruritic or soothing ingredients. in Pruritus, sponsored by Dolores Lopez Romero. Not yet recruiting at 1 site in Spain. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Dolores Lopez Romero · Not applicable, Interventional, and Treatment

Updated Nov 10, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

Skin prick tests are among the most widely used diagnostic procedures for IgE-mediated allergic diseases, such as rhinitis, bronchial asthma, and food allergy. They are rapid, cost-effective, and sensitive techniques; however, they may cause local discomfort and itching (pruritus), which can be particularly distressing for children.

In pediatric nursing, improving patient comfort and reducing anxiety are key priorities. Various interventions, including topical corticosteroids, ice, and cold, wet compresses, have been used to relieve itching, but none has been shown to effectively reduce pruritus following skin prick testing. Available evidence suggests that post-prick test itching usually resolves spontaneously and that topical corticosteroids have not demonstrated clear superiority over simple interventions. Therefore, this study will evaluate whether applying the soothing topical cream Ceramol Beta Complex® effectively relieves itching, improves the quality of nursing care, and enhances patient well-being.Applying Ceramol Beta Complex® after skin prick test results have been read may reduce the intensity or duration of itching in children aged 6-12 years compared with a moisturizing cream without specific soothing active ingredients.To evaluate the efficacy of Ceramol Beta Complex® cream in reducing pruritus associated with positive skin prick test reactions in pediatric patients.This prospective, randomized study will include children aged 6-12 years undergoing skin prick testing in a pediatric allergy clinic. A total of 100 children will be enrolled and randomly allocated to one of two groups: (A) an intervention group, which will receive Ceramol Beta Complex® cream, or (B) a control group, which will receive the emollient cream routinely used in our pediatric allergy clinics

02

Conditions studied

  • Pruritus

Browse trials for

Keywords

  • skin prick testing
  • pruritus
  • pediatric allergy
  • Ceramol Beta Complex
  • topical cream
  • patient comfort
  • pediatric nursing
03

In context

Pruritus

490 studies on the registry are indexed under Pruritus; 93 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 422 interventional studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

This is the only study on the registry with Dolores Lopez Romero as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Boys and girls aged 6-12 years.
  • Clinical indication for allergy skin prick testing as part of routine clinical care.
  • Children undergoing skin prick testing for the first time, in order to minimize suggestion or conditioning bias resulting from previous experiences.
  • Children with a positive result (wheal size ≥ 3 × 3 mm) to at least one allergen extract.
  • Written signed by parents or legal guardians, and the child's assent when appropriate.

Exclusion criteria

Exclusion Criteria

  • Active skin lesions at the site of skin prick testing (forearm).
  • Known allergy to any of the ingredients of Ceramol Beta Complex® cream.
  • Known allergy to any of the ingredients of the emollient cream routinely used in our clinic.
  • Treatment within the previous 5 days with systemic or topical antihistamines; topical applied to the forearm within the previous week; oral corticosteroids within the previous 4 weeks; or other products that may interfere with the results.
  • Patients who have previously undergone skin prick testing at our clinic.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Sham comparator
    control group

    Emollient cream application

    Other: The control group will receive an emollient cream (B), prepared by the hospital pharmacy, without antipruritic or soothing ingredients.

  • Active comparator
    Emollient Cream( SOC)

    Emollient Cream( SOC)

    Other: Application of antipruritic cream

Interventions

  • OtherApplication of antipruritic cream

    Application of antipruritic cream after skin prick test readings.

  • OtherThe control group will receive an emollient cream (B), prepared by the hospital pharmacy, without antipruritic or soothing ingredients.

    Apply a small amount of emollient cream after skin prick testing.

06

What researchers measure

Primary outcomes

  1. Effect of Ceramol Beta Complex® on Pruritus in Pediatric Patient

    Evaluation of Pruritus Score Changes Following Ceramol Beta Complex® Treatment in Pediatric Patients with Positive Skin Prick Tests: A Controlled Study

    Time frame: Reduction in Itching from Cream Application to 30 Minutes Post-Application

Secondary outcomes

  1. Pruritus Intensity: Ceramol Beta Complex® vs. Emollient at T0 and T5

    To compare pruritus intensity following the application of Ceramol Beta Complex® versus a standard emollient cream without active soothing ingredients, routinely used in the Pediatric Allergy Clinic after skin prick testing.

    Time frame: at T0 (before cream application) and T5 (5 minutes after application).

  2. Pruritus Reduction: Ceramol Versus Standard Moisturizer

    To determine whether the application of Ceramol Beta Complex® produces a reduction of ≥2 points on the pruritus scale compared with the standard moisturizer routinely used

    Time frame: 30 Minutes Post-Application

07

Study locations

1 site
08

References and documents

Publications

  • Reich A, Riepe C, Anastasiadou Z, Medrek K, Augustin M, Szepietowski JC, Stander S. Itch Assessment with Visual Analogue Scale and Numerical Rating Scale: Determination of Minimal Clinically Important Difference in Chronic Itch. Acta Derm Venereol. 2016 Nov 2;96(7):978-980. doi: 10.2340/00015555-2433. No abstract available. PubMed 27068455 ↗
  • Haydek CG, Love E, Mollanazar NK, Valdes Rodriguez R, Lee H, Yosipovitch G, Tharp MD, Hanifin JM, Chen KH, Chen SC. Validation and Banding of the ItchyQuant: A Self-Report Itch Severity Scale. J Invest Dermatol. 2017 Jan;137(1):57-61. doi: 10.1016/j.jid.2016.06.633. Epub 2016 Aug 10. PubMed 27521593 ↗
  • Stewart S, Boscher J, Hossain J, McGeady SJ, Yousef E. Pruritus from allergy skin tests in children: Comparing remedies. Ann Allergy Asthma Immunol. 2016 Oct;117(4):429-430. doi: 10.1016/j.anai.2016.07.019. Epub 2016 Aug 10. No abstract available. PubMed 27522109 ↗

Individual participant data

Plan to share: No — It's not necessary

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.

Of 85 non-industry interventional studies with no phase under Pruritus, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's planned 7 months is close to that.

Counting every sponsor, half of 101 studies reached it within 7 months; a quarter within 3 and three quarters within 13.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 10, 2026
StartEst.
Nov 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07927634
Lead sponsor
Dolores Lopez Romero
Responsible party
Dolores Lopez Romero (Specialized Nurse, Hospital General Universitario Gregorio Marañon) — Sponsor-investigator
First posted
Nov 10, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Nov 10, 2026

Study contacts

Maria Dolores MD López Romero, Enfermera Especialista Pediátr
Contact
mlromero@salud.madrid.org
607580014

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion